WARNING: SEVERE HYPERSENSITIVITY REACTIONS, INFUSION-ASSOCIATED
REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE
Hypersensitivity Reactions Including Anaphylaxis
Patients treated with NEXVIAZYME have experienced life-threatening
hypersensitivity reactions, including anaphylaxis. Appropriate medical
support measures, including cardiopulmonary resuscitation equipment,
should be readily available during NEXVIAZYME administration. If a
severe hypersensitivity reaction (e.g., anaphylaxis) occurs,
NEXVIAZYME should be discontinued immediately and appropriate medical
treatment should be initiated. In patients with severe
hypersensitivity reaction, a desensitization procedure to NEXVIAZYME
may be considered.
Infusion-Associated Reactions (IARs)
Patients treated with NEXVIAZYME have experienced severe IARs. If
severe IARs occur, consider immediate discontinuation of NEXVIAZYME,
initiation of appropriate medical treatment, and the benefits and
risks of readministering NEXVIAZYME following severe IARs. Patients
with an acute underlying illness at the time of NEXVIAZYME infusion
may be at greater risk for IARs. Patients with advanced Pompe disease
may have compromised cardiac and respiratory function, which may
predispose them to a higher risk of severe complications from IARs.
Risk of Acute Cardiorespiratory Failure in Susceptible Patients
Patients susceptible to fluid volume overload, or those with acute
underlying respiratory illness or compromised cardiac or respiratory
function for whom fluid restriction is indicated may be at risk of
serious exacerbation of their cardiac or respiratory status during
NEXVIAZYME infusion. More frequent monitoring of vitals should be
performed during NEXVIAZYME infusion.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Anaphylaxis: See
Boxed WARNING. Prior to NEXVIAZYME administration, consider pretreating
with antihistamines, antipyretics, and/or corticosteroids. The risks and
benefits of readministering NEXVIAZYME following severe hypersensitivity
reaction (including anaphylaxis) should be considered. If a mild or
moderate hypersensitivity reaction occurs, the infusion rate may be
slowed or temporarily stopped.
See Boxed WARNING. IARs may still occur in patients after receiving
pretreatment. If mild or moderate IARs occur regardless of pretreatment,
decreasing the infusion rate or temporarily stopping the infusion may
ameliorate the symptoms.
Risk of Acute Cardiorespiratory Failure in Susceptible
See Boxed WARNING.
The most common adverse reactions (>5%) were headache, fatigue,
diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting,
dyspnea, erythema, paresthesia and urticaria.
NEXVIAZYME (avalglucosidase alfa-ngpt) is indicated for the treatment of
patients 1 year of age and older with late-onset Pompe disease
[lysosomal acid alpha-glucosidase (GAA) deficiency].
Please see full
for complete details, including Boxed WARNING.